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Opioid Free Anesthesia and Major Spine Surgery

Primary Purpose

Opioid Use, Postoperative Pain, Spine Disease

Status
Completed
Phase
Not Applicable
Locations
Lebanon
Study Type
Interventional
Intervention
opioid free Anesthesia vs Opioid based Anesthesia
Sponsored by
Lebanese American University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Use focused on measuring Lidocaine, Dexmedetomidine, Opioid-free

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age group: 18-80 years old
  • American Society of Anesthesiologists (ASA )class I, II and III
  • Elective spine posterior instrumentation surgery of at least two levels.

Exclusion Criteria:

  • Renal, hepatic or cardiac insufficiency.
  • Alcohol or drug abuse.
  • Psychiatric disease.
  • Allergy or contraindication to any of the study drugs.
  • Inability to comprehend pain assessment or inability to use a Patient Controlled Analgesia (PCA) device.

Sites / Locations

  • LAU Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Opioid based Anesthesia

Opioid Free Anesthesia

Arm Description

General anesthesia will be induced using Propofol , fentanyl , and Rocuronium . Ketamine will be administered on induction of anesthesia with the same dose to be repeated every hour. Anesthesia will be maintained with Remi-fentanyl , sevoflurane and nitrous oxide.

-General anesthesia will be induced using dexmedetomidine and lidocaine started 10 minutes before induction, Propofol and Rocuronium . Ketamine will be administered on induction of anesthesia with the same dose to be repeated every hour. Anesthesia will be maintained with IV infusion of dexmedetomidine , lidocaine , sevoflurane and nitrous oxide.

Outcomes

Primary Outcome Measures

Postoperative morphine consumption
After the surgery the patient will go to the PACU (Post Anesthesia Care Unit). the patient will receive morphine if the pain score is more than 4. the total dose of morphine in mg (milligrams) will be documented. Before discharge from the PACU, the patient will have a PCA (Patient Controlled Analgesia) morphine,All attempts and given values of morphine In mg obtained from the PCA machine will be documented at 0, 1, 2, 4, 6, 12, 18, and 24 hours and every 6 hours thereafter up to 48 hours post surgery.. And the total amount of morphine in mg will be calculated for 48 hours

Secondary Outcome Measures

Postoperative morphine Side effects: Sedation score .
-Sedation score: 0 alert Mild, drowsy , easy to awake moderate, easy to arouse Severe: somnolent difficult to arouse 4:sleeping The Sedation score will be documented at 0, 1, 2, 4, 6, 12, 18, and 24 hours and every 6 hours thereafter up to 48 hours.
Postoperative morphine Side effects:Respiratory depression
Assess the respiratory rate : The number of breaths per minute. In practice, the respiratory rate is usually determined by counting the number of times the chest rises or falls per minute. The respiratory rate will be documented at 0, 1, 2, 4, 6, 12, 18, and 24 hours and every 6 hours thereafter up to 48 hours.
Postoperative morphine Side effects: Nausea vomiting
Degree of nausea vomiting using the verbal rating score from 0 to 10 : 0= no nausea/ Vomiting, 10: worst possible nausea vomiting. The degree of nausea vomiting will be documented at 0, 1, 2, 4, 6, 12, 18, and 24 hours and every 6 hours thereafter up to 48 hours.
Postoperative morphine Side effects: Itching
Itching: presence or absence The presence or absence of itching will be documented at 0, 1, 2, 4, 6, 12, 18, and 24 hours and every 6 hours thereafter up to 48 hours.
Postoperative pain score
Measure the pain score using the Visual Analogue Scale (VAS), The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be' The patient is asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the subject's pain. The score ranges from 0 to 100 mm. A higher score indicates greater pain intensity. The distribution pain is the following:no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).Postoperative pain will be measured using Verbal Analogue Scale (VAS) at 0, 1, 2, 4, 6, 12, 18, and 24 hours to be repeated every 6 hours thereafter up to 48 hours post surgery

Full Information

First Posted
January 16, 2018
Last Updated
February 16, 2023
Sponsor
Lebanese American University
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1. Study Identification

Unique Protocol Identification Number
NCT03417193
Brief Title
Opioid Free Anesthesia and Major Spine Surgery
Official Title
Opioid Free Anesthesia in Major Spine Surgery: a Prospective, Double-blinded, Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 29, 2018 (Actual)
Primary Completion Date
February 16, 2023 (Actual)
Study Completion Date
February 16, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lebanese American University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study compares the intraoperative opioid free anesthesia approach in multilevel spine posterior instrumentation surgery to a conventional opioid-based anesthesia. Half of participants will receive opioid free anesthesia with dexmedetomidine, lidocaine and ketamine while the other half will receive opioid based anesthesia with fentanyl, remi-fentanyl and ketamine
Detailed Description
Opioid analgesics are commonly used in clinical practice for per and postoperative pain treatment. However their use is associated with a lot of undesirable effects. From this comes the idea of using opioid free anesthesia intra-operatively in an attempt to decrease opioids postoperative use and accordingly, their associated side effects. Intravenous (IV) lidocaine has been found to have analgesic, antihyperalgesic, and anti-inflammatory properties. It was found to significantly improve postoperative pain, when its intraoperative use was compared with placebo . Dexmedetomidine is a selective alpha-two adrenergic receptor agonist that has antinociceptive, analgesic, opioid sparing and sedative properties. Similar to lidocaine, dexmedetomidine was shown to lower postoperative pain, opioid consumption and accordingly, opioid related side effects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use, Postoperative Pain, Spine Disease
Keywords
Lidocaine, Dexmedetomidine, Opioid-free

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Opioid based Anesthesia
Arm Type
Active Comparator
Arm Description
General anesthesia will be induced using Propofol , fentanyl , and Rocuronium . Ketamine will be administered on induction of anesthesia with the same dose to be repeated every hour. Anesthesia will be maintained with Remi-fentanyl , sevoflurane and nitrous oxide.
Arm Title
Opioid Free Anesthesia
Arm Type
Active Comparator
Arm Description
-General anesthesia will be induced using dexmedetomidine and lidocaine started 10 minutes before induction, Propofol and Rocuronium . Ketamine will be administered on induction of anesthesia with the same dose to be repeated every hour. Anesthesia will be maintained with IV infusion of dexmedetomidine , lidocaine , sevoflurane and nitrous oxide.
Intervention Type
Drug
Intervention Name(s)
opioid free Anesthesia vs Opioid based Anesthesia
Intervention Description
Compare the opioid based anesthesia with Fentanyl and Remifentanyl to opioid free anesthesia with dexmedetomidine and lidocaine and their effect on postoperative pain.
Primary Outcome Measure Information:
Title
Postoperative morphine consumption
Description
After the surgery the patient will go to the PACU (Post Anesthesia Care Unit). the patient will receive morphine if the pain score is more than 4. the total dose of morphine in mg (milligrams) will be documented. Before discharge from the PACU, the patient will have a PCA (Patient Controlled Analgesia) morphine,All attempts and given values of morphine In mg obtained from the PCA machine will be documented at 0, 1, 2, 4, 6, 12, 18, and 24 hours and every 6 hours thereafter up to 48 hours post surgery.. And the total amount of morphine in mg will be calculated for 48 hours
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Postoperative morphine Side effects: Sedation score .
Description
-Sedation score: 0 alert Mild, drowsy , easy to awake moderate, easy to arouse Severe: somnolent difficult to arouse 4:sleeping The Sedation score will be documented at 0, 1, 2, 4, 6, 12, 18, and 24 hours and every 6 hours thereafter up to 48 hours.
Time Frame
48 hours post operative.
Title
Postoperative morphine Side effects:Respiratory depression
Description
Assess the respiratory rate : The number of breaths per minute. In practice, the respiratory rate is usually determined by counting the number of times the chest rises or falls per minute. The respiratory rate will be documented at 0, 1, 2, 4, 6, 12, 18, and 24 hours and every 6 hours thereafter up to 48 hours.
Time Frame
48 hours
Title
Postoperative morphine Side effects: Nausea vomiting
Description
Degree of nausea vomiting using the verbal rating score from 0 to 10 : 0= no nausea/ Vomiting, 10: worst possible nausea vomiting. The degree of nausea vomiting will be documented at 0, 1, 2, 4, 6, 12, 18, and 24 hours and every 6 hours thereafter up to 48 hours.
Time Frame
48 hours
Title
Postoperative morphine Side effects: Itching
Description
Itching: presence or absence The presence or absence of itching will be documented at 0, 1, 2, 4, 6, 12, 18, and 24 hours and every 6 hours thereafter up to 48 hours.
Time Frame
48 hours
Title
Postoperative pain score
Description
Measure the pain score using the Visual Analogue Scale (VAS), The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be' The patient is asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the subject's pain. The score ranges from 0 to 100 mm. A higher score indicates greater pain intensity. The distribution pain is the following:no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).Postoperative pain will be measured using Verbal Analogue Scale (VAS) at 0, 1, 2, 4, 6, 12, 18, and 24 hours to be repeated every 6 hours thereafter up to 48 hours post surgery
Time Frame
48 hours post operative.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age group: 18-80 years old American Society of Anesthesiologists (ASA )class I, II and III Elective spine posterior instrumentation surgery of at least two levels. Exclusion Criteria: Renal, hepatic or cardiac insufficiency. Alcohol or drug abuse. Psychiatric disease. Allergy or contraindication to any of the study drugs. Inability to comprehend pain assessment or inability to use a Patient Controlled Analgesia (PCA) device.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanane MD
Organizational Affiliation
Lebanese American University/ LAU Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
LAU Medical Center
City
Beirut
Country
Lebanon

12. IPD Sharing Statement

Plan to Share IPD
No

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Opioid Free Anesthesia and Major Spine Surgery

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